Genoray’s CBCT ‘GT300’ Receives U.S. FDA 510(k) Clearance (2025.10.17)

X-ray diagnostic equipment specialist Genoray (CEO Park Byung-wook) announced on the 17th that its dental CBCT, the ‘GT300’, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The GT300 is a CBCT system that supports diagnosis and treatment planning by capturing 3D images of the teeth and facial area. Since its launch last year, it has successively obtained certifications from the MFDS (Korea), NRTL (North America), and ANVISA (Brazil). With this FDA approval, Genoray has established a bridgehead for a full-scale entry into the U.S. market.

The GT300 is recognized for its enhanced usability and durability, featuring ‘Smart Positioning’ that automatically retrieves a patient’s previous visit data and large Field of View (FOV) options that can be selected based on the purpose of the procedure.

Furthermore, it is equipped with ‘Aiel’, an image enhancement technology developed in-house by Genoray, which boosts performance to deliver high resolution and accuracy even with low-dose radiation.

Founded in 2001, Genoray is a global healthcare company that manufactures its own key components and currently supplies products to over 80 countries worldwide.

The company is accelerating its expansion into overseas markets by securing three consecutive global certifications over the past six months: the ANVISA certification for the GT300 in Brazil, FDA 510(k) approval for HESTIA, and this latest FDA clearance for the GT300.